CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
FDA 510(k) clearance K072790 · decided 2008-01-11
Clearance details
- K-number
- K072790
- Device name
- CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
- Applicant
- Confluent Surgical,Inc
- Decision
- Substantially Equivalent
- Date received
- 2007-10-01
- Decision date
- 2008-01-11
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.